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Head Position for Endotracheal Intubation (THHEIEIA)

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ClinicalTrials.gov Identifier: NCT02418741
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Mi Ja Yun, MD, PhD, National Medical Center, Seoul

Study Description
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Brief Summary:
The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.

Condition or disease Intervention/treatment Phase
Intubation; Difficult Other: Neck flexion Not Applicable

Detailed Description:
The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: The Degree of Neck Flexion Does Not Influence on the Laryngeal View and Discomfort During Endotracheal Intubation in Adult Patients
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Degree of neck flextion
Two degrees of neck flexion were achieved using a 4 cm or 8 cm height of pillow
 Other: Neck flexion
Patient's neck was flexed using a 4 cm or 8 cm height of pillow


Outcome Measures
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Primary Outcome Measures :
  1. Laryngeal view as index of ease of insertion [ Time Frame: one year ]
    Cormack Lehane grade during endotracheal intubation


Secondary Outcome Measures :
  1. Discomfort of anesthesiologist during endotracheal intubation [ Time Frame: one year ]
    Anesthesiologist can feel difficulties in mouth opening and in insertion of laryngoscopic blade into oral cavity according to the degrees of neck flexion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective operation time ≤2hrs
  • American Society of Anesthesiologist, Physical Status 1 or 2
  • age ; 18 - 90 years

Exclusion Criteria:

  • patient has upper respiratory infection symptoms
  • limited mouth opening
  • teeth problems
  • expecting difficult airway
  • congenital heart disease
  • patient has a possibility of aspiration pneumonia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418741


Locations
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Korea, Republic of
National Medical Center
Seoul, Junggu, Korea, Republic of
Sponsors and Collaborators
National Medical Center, Seoul
Investigators
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Study Director: Mija Yun, staff national medical center
More Information
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Responsible Party: Mi Ja Yun, MD, PhD, Principal investigator, National Medical Center, Seoul
ClinicalTrials.gov Identifier: NCT02418741    
Other Study ID Numbers: H-1312/037-002
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015